PRISMAFLEX TPE 107144

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-28 for PRISMAFLEX TPE 107144 manufactured by Baxter Healthcare - Meyzieu.

Event Text Entries

[112703573] The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[112703574] It was reported that a patient undergoing a therapeutic plasma exchange (tpe) treatment with a prismaflex tpe set and a prismaflex control unit experienced generalized hives, respiratory problems and was hospitalized. Albumin and/or fresh frozen plasma were used during the tpe treatment. There was no medical intervention reported for this event and the reporter declined to provide additional information.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010182-2018-00060
MDR Report Key7648190
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-06-28
Date of Report2018-06-28
Date Mfgr Received2018-06-01
Date Added to Maude2018-06-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1BAXTER HEALTHCARE - MEYZIEU
Manufacturer Street7, AV LIONEL TERRAY, B.P. 126
Manufacturer CityMEYZIEU CEDEX RHONE 69883
Manufacturer CountryFR
Manufacturer Postal Code69883
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRISMAFLEX TPE
Generic NameSEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA
Product CodeMDP
Date Received2018-06-28
Model NumberNA
Catalog Number107144
Lot NumberASKU
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - MEYZIEU
Manufacturer AddressMEYZIEU CEDEX RHONE


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2018-06-28

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